Suicide Prevention
Conditions
Keywords
Suicide, Middle-aged and Older Adults, Cognitive Reappraisal, Emotion Regulation
Brief summary
The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
Detailed description
The Investigators developed a novel psychosocial intervention called Cognitive Reappraisal Intervention for Suicide Prevention (CRISP), which aims to improve cognitive reappraisal ability (i.e. the ability to modify the appraisal of a situation to alter its emotional significance) (target), and reduce suicide risk (outcome). The conceptual framework views suicidal ideation and behavior as failed attempts to regulate negative emotions and by improving cognitive reappraisal, an effective emotion regulation strategy, the investigators expect to reduce suicide risk. This theory is supported by studies showing that unsuccessful attempts to regulate negative emotions and decreased cognitive reappraisal are associated with increased suicidal ideation and behavior. The R61 phase is a proof-of-principle phase and its goals are to optimize CRISP and test its engagement with cognitive reappraisal. Certified social workers will administer 12 weekly sessions of CRISP to 40 middle-aged and older adults (50-90 years old) after a suicide-related hospitalization. Research assistants, unaware of the study aims, will conduct assessments at study entry (hospital admission), discharge, 6 and 12 weeks post-discharge. Target engagement will be assessed with EEG assessments during a standard pictured-based stimuli and our novel cognitive reappraisal paradigm. The R33 phase aims to provide further evidence of target engagement of the optimized CRISP in a larger sample, evaluate the relationship of cognitive reappraisal with suicide risk as measured with Columbia Suicide Severity Rating Scale (C-SSRS) and estimate implementation parameters for a large-scale clinical trial. A different sample of 90 middle-aged and older adults (using the same inclusion/exclusion criteria as for the R61 phase) will be randomized to CRISP or to Supportive Therapy (ST, a control treatment not designed to improve emotion regulation). Assessments will be conducted on admission, at discharge, and at 6, 12 and 24 weeks post-discharge. Primary aims are: 1) CRISP participants will show improvement in cognitive reappraisal ability from discharge to end of treatment; and 2) improvement in cognitive reappraisal ability will be associated with suicide risk over 24 weeks.
Interventions
BEHAVIORALCognitive Reappraisal Intervention for Suicide Prevention
Cognitive Reappraisal Intervention for Suicide Prevention, or CRISP, is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.
BEHAVIORALSupportive Therapy
ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors
Sponsors
Stanford University
Florida State University
National Institute of Mental Health (NIMH)
Rutgers University
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 50 years and older * Diagnosis (based on SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 depression or anxiety diagnosis, including major depressive disorder, bipolar depression, depressive disorder Not Elsewhere Classified, anxiety disorder Not Elsewhere Classified, adjustment disorder with anxiety and depressed mood (but without any of the diagnoses shown under
Exclusion criteria
) * Recent hospitalization for suicidal ideation or suicide attempt. At hospital admission, Columbia Suicide Severity Rating Scale greater or equal to 3, Active Suicidal Ideation with any methods or a suicide attempt. * Patients with any degree of suicidal ideation at discharge (Columbia Suicide Severity Rating greater or equal to 0) will be included. * Patients who are on psychotropics and on after-care community psychotherapy will also be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Baseline, 6, 12 | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks. These values are the mean result of a composite measure (50% of each task) of μVoltage during the Autobiographical Affective Regulation Task (AART) and a standard picture-based emotion regulation task. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R33). |
| Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) | Baseline - Week 12 | The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks at Baseline and Week 12. These values are the mean result of a composite measure (50% of each task) of a) a standardized picture-based emotion regulation task in parietal (Pz) site during 1600-2000ms and b) AART in parietal (Pz) site during 0-3000 ms. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R61). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33) | Baseline - Week 12 | The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-5, with lower numbers indicating less severity and higher numbers more severity. The outcome variable is scored with respect to the most severe type of ideation from the following Yes or No questions Wish to be Dead, Non-Specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, and Active Suicidal Ideation with Specific Plan and Intent. A response of Yes yields a score of 1 and a response of No yields a score of 0. The highest score a participant can receive is 5. If the answer to question 2 is Yes then questions 3, 4, and 5 are asked. Only if the questions 1 and 2 are recorded as Yes' the outcome the Intensity of Ideation is completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRISP (R61) Experimental: CRISP (R61) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. | 35 |
| CRISP (R33) Experimental: CRISP (R33) Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH. | 48 |
| CRISP (ST) (R33) Active Comparator: Supportive Therapy (ST) (R33) Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors. | 24 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| CRISP R33 | Adverse Event | 0 | 9 | 5 |
| CRISP R33 | Lack of Efficacy | 0 | 3 | 2 |
| CRISP R33 | Lost to Follow-up | 0 | 5 | 4 |
| CRISP R33 | Physician Decision | 0 | 3 | 1 |
| CRISP R33 | Transportation | 0 | 2 | 1 |
| CRISP R33 | Withdrawal by Subject | 0 | 9 | 1 |
| CRISP R61 | Adverse Event | 5 | 0 | 0 |
| CRISP R61 | Dropped before therapy | 5 | 0 | 0 |
| CRISP R61 | Lost to Follow-up | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | CRISP (R61) | CRISP (R33) | CRISP (ST) (R33) | Total |
|---|---|---|---|---|
| Age, Continuous | 60.80 years STANDARD_DEVIATION 8.47 | 60.94 years STANDARD_DEVIATION 8.3 | 60.63 years STANDARD_DEVIATION 9.05 | 60.82 years STANDARD_DEVIATION 8.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 46 Participants | 19 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 27 Participants | 40 Participants | 17 Participants | 84 Participants |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 14 Participants | 66 Participants |
| Sex: Female, Male Male | 9 Participants | 22 Participants | 10 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 48 | 0 / 24 |
| other Total, other adverse events | 0 / 35 | 2 / 48 | 1 / 24 |
| serious Total, serious adverse events | 8 / 35 | 13 / 48 | 4 / 24 |
Outcome results
Primary
Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33)
The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks. These values are the mean result of a composite measure (50% of each task) of μVoltage during the Autobiographical Affective Regulation Task (AART) and a standard picture-based emotion regulation task. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R33).
Time frame: Baseline, 6, 12
Population: This is the analyses of the R33 phase of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CRISP (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Baseline | 5.61 μVoltage | Standard Deviation 15.97 |
| CRISP (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Week 6 | 1.51 μVoltage | Standard Deviation 9.1 |
| CRISP (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Week 12 | 2.09 μVoltage | Standard Deviation 6.2 |
| CRISP (ST) (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Baseline | 4.38 μVoltage | Standard Deviation 9.2 |
| CRISP (ST) (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Week 6 | 0.48 μVoltage | Standard Deviation 12.2 |
| CRISP (ST) (R33) | Change in Late Positive Potential, as Measured by the Electroencephalagram (EEG), Autobiographical Affective Regulation Task (AART), and a Standard Picture-based Emotion Regulation Task. (Only for the R33) | Week 12 | 0.78 μVoltage | Standard Deviation 5.22 |
Primary
Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61)
The reported values for each assessment represent μVoltage (a unit of electrical potential) during EEG tasks at Baseline and Week 12. These values are the mean result of a composite measure (50% of each task) of a) a standardized picture-based emotion regulation task in parietal (Pz) site during 1600-2000ms and b) AART in parietal (Pz) site during 0-3000 ms. Higher values reflect stronger emotional response and lower cognitive reappraisal ability. The results are interpreted comparatively to other values (other groups or other time points) (Only for the R61).
Time frame: Baseline - Week 12
Population: Analyzed subjects for CRISP R61. Out of 35 participants, 12 participants' data were not used for this analysis: 5 dropped before starting therapy, 5 had adverse event, and 2 were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CRISP (R61) | Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) | Baseline | 4.99 μVoltage | Standard Deviation 4.45 |
| CRISP (R61) | Changes in Electrocortical Measures (i.e., Late Positive Potential, LPP) (Only for the R61) | Week 12 | 3.10 μVoltage | Standard Deviation 3.33 |
Other Pre-specified
Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33)
The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-5, with lower numbers indicating less severity and higher numbers more severity. The outcome variable is scored with respect to the most severe type of ideation from the following Yes or No questions Wish to be Dead, Non-Specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, and Active Suicidal Ideation with Specific Plan and Intent. A response of Yes yields a score of 1 and a response of No yields a score of 0. The highest score a participant can receive is 5. If the answer to question 2 is Yes then questions 3, 4, and 5 are asked. Only if the questions 1 and 2 are recorded as Yes' the outcome the Intensity of Ideation is completed.
Time frame: Baseline - Week 12
Population: This analysis is for R33 participants only. R33 participants who did not complete Week 12 were excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRISP (R33) | Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33) | 0.21 score on a scale | Standard Deviation 0.98 |
| CRISP (ST) (R33) | Change in Suicide Severity, as Measured by the Columbia Suicide Severity Rating Scale (CSSR-S) (Only for the R33) | -0.500 score on a scale | Standard Deviation 1.45 |